evaluate the safety and efficacy of Inshape X® intradermal filler

A single-arm, before- after clinical study to evaluate the safety and efficacy of Inshape X® intradermal filler containing 150mg poly-L-lactic acid (NanoDaru Pajuhan Pardis) for correction of moderate to severe nasolabial folds

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150101020514N26

Enrollment

Registered

2023-11-12

Start date

2023-11-22

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin aging.

Interventions

Intervention group: receiving a subcutaneous dose of inshape-x-scalp suspension (poly-L-lactic acid of Pardis Nano Darou Pazhouhan Pharmaceutical Company) containing 150 mg, using one of the linear th

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 18–65-year-old men and women Moderate to severe nasolabial folds based on Allergan criteria. The opportunity to accompany the visit programs and study process. Signing the informed consent form and agree to a 6-month follow-up.

Exclusion criteria

Exclusion criteria: History of type 1 allergic reactions or anaphylaxis reactions Previous allergy to filler and lidocaine ingredients History of hypertrophic and colloid scars or bleeding disorders in the nasolabial region Active inflammatory processes, infection, lesion (cancerous/noncancerous) in the nasolabial region Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Severity of nasolabial folds. Timepoint: Before intervention and 4 weeks later. Method of measurement: 5 scale Allergan photo numeric grading.	—

Secondary

Measure	Time frame
Severity of nasolabial folds. Timepoint: Before intervention, 3, 6 and 12 months later. Method of measurement: 5 scale Allergan photo numeric grading.;Severity of nasolabial folds. Timepoint: Before intervention, 1, 3, 6 and 12 months later. Method of measurement: Based on GAIS scale compared to base mode.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 1, 6 and 12 months later. Method of measurement: Visioface camera.	—

Measure

Time frame

Severity of nasolabial folds. Timepoint: Before intervention, 3, 6 and 12 months later. Method of measurement: 5 scale Allergan photo numeric grading.;Severity of nasolabial folds. Timepoint: Before intervention, 1, 3, 6 and 12 months later. Method of measurement: Based on GAIS scale compared to base mode.;Depth, area and volume of nasolabial fold. Timepoint: Before intervention, 1, 6 and 12 months later. Method of measurement: Visioface camera.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Samadi

Tehran University of Medical Sciences

aniseh_samadi@yahoo.com+98 21 8896 0880

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026